Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000716864
Ethics application status
Approved
Date submitted
4/07/2012
Date registered
5/07/2012
Date last updated
20/02/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of an online system for health, called Healthy.me, in patients with asthma
Scientific title
The effect of an internet intervention, called Healthy.me, on the use of written asthma action plans in patients with asthma
Secondary ID [1] 280778 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diagnosed asthma 286836 0
Condition category
Condition code
Respiratory 287147 287147 0 0
Asthma
Public Health 287150 287150 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Free use of the full version of the Healthy.me website to manage their asthma for 12 months. This version includes a Personally Controlled Health Management System (PCHMS) and social interaction features. Participants can enter descriptions of symptoms, spirometry measures, medication usage, report the asthma action plan, read tailored information about asthma, use forums and polls, access personal records, and book an appointment to see their healthcare professional.
Intervention code [1] 285203 0
Treatment: Other
Intervention code [2] 285209 0
Behaviour
Intervention code [3] 285210 0
Prevention
Comparator / control treatment
Delayed access to Healthy.me by around 12 months. Participants can access generic information about asthma but are not able to get full access to Healthy.me until the end of study.
Control group
Active

Outcomes
Primary outcome [1] 287459 0
Number of participants who have obtained, or have updated during the study, their personalized written asthma action plan. This outcome is assessed by pre- and post-study questionnaires and cross-validated by audits.
Timepoint [1] 287459 0
at 12 months after randomisation
Secondary outcome [1] 298196 0
Number of visits (planned and unplanned) to a GP, measured by questionnaires and cross-validated for the intervention group with log-files of usage of Healthy.me
Timepoint [1] 298196 0
at 12 months
Secondary outcome [2] 298197 0
Asthma control as measured by the Asthma Control Questionnaire
Timepoint [2] 298197 0
monthly from baseline for 12 months
Secondary outcome [3] 298198 0
Usage patterns (number and timing of hits, duration of access, uptake of specific functions) of Healthy.me
Timepoint [3] 298198 0
at 12 months
Secondary outcome [4] 298199 0
Asthma exacerbation as measured by the Asthma Exacerbation Questionnaire
Timepoint [4] 298199 0
monthly from baseline for 12 months
Secondary outcome [5] 298201 0
Impact of asthma (e.g. days lost from work or school, reported in post-study questionnaire and in the Asthma Control Questionnaire on a monthly basis)
Timepoint [5] 298201 0
at 12 months
Secondary outcome [6] 298202 0
Attrition rate for the use of Healthy.me
Timepoint [6] 298202 0
at 12 months
Secondary outcome [7] 298203 0
Healthy.me satisfaction and utilization assessed in post-study questionnaire or calculated from collected data
Timepoint [7] 298203 0
at 12 months
Secondary outcome [8] 298204 0
Number of participants adhering to a written asthma action plan, assessed in post-study questionnaire
Timepoint [8] 298204 0
at 12 months

Eligibility
Key inclusion criteria
- Access to the Internet - Doctor diagnosis of asthma - Adequate English reading and written ability
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Internet-based recruitment methods will be used to invite patients with asthma to participate in the study: * advertisement on online noticeboards (e.g. Gumtree). * Promotion of the study on Facebook and Twitter * Asthma Foundation NSW will send an email to its members via its regular newsletters and/or other email mechanisms to inform them about the study. In addition, a call for participation will be advertised on their website. Participants meeting eligibility criteria will be invited to visit the study website and/or contact the researcher for participation and further information.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation to the intervention or control group according to a sequence generated by a computerized random-number generator. The randomisation will be stratified by gender and asthma severity (intermittent vs. persistent asthma). The randomisation sequence generation, participant enrolment and group allocation processes in this study are computerised online and do not involve interference from the investigators.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 285565 0
Government body
Name [1] 285565 0
NHMRC
Country [1] 285565 0
Australia
Primary sponsor type
University
Name
Centre for Health Informatics, UNSW
Address
Centre for Health Informatics
Level 1 AGSM Building (G27)
University of New South Wales
SYDNEY NSW 2052
Country
Australia
Secondary sponsor category [1] 284402 0
None
Name [1] 284402 0
Address [1] 284402 0
Country [1] 284402 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287581 0
UNSW HREC
Ethics committee address [1] 287581 0
University of New South Wales
SYDNEY NSW 2052
Ethics committee country [1] 287581 0
Australia
Date submitted for ethics approval [1] 287581 0
04/05/2012
Approval date [1] 287581 0
05/06/2012
Ethics approval number [1] 287581 0
HC12213

Summary
Brief summary
The aim of this project is to assess the efficacy of an online system designed for patients and health care consumers, called Healthy.me, to support health management. Healthy.me provides patients and consumer condition specific information, as well as online tools to manage their care including a personal health record. Our primary hypothesis is that use of Healthy.me for patients with asthma will increase possession and uptake of a written asthma action plan. This randomized controlled trial will also specifically test whether system use is associated with the following secondary outcome measures: i) significant improvement in asthma control, ii) increased compliance according to written asthma action plan, iii) reduced unplanned utilization of health services, iv) reduced frequency of exacerbations, and iv) improved quality of life over 12 months. Patients and consumers are increasingly using online systems to make health decisions and manage their health but we still know little about their patterns of use and impact. This study will make a specific and significant contribution to our understanding of the effectiveness of online systems for patients and healthcare consumers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34392 0
Dr Annie Lau
Address 34392 0
Centre for health Informatics Level 1 AGSM Building (G27) University of New South Wales SYDNEY NSW 2052
Country 34392 0
Australia
Phone 34392 0
+61 02938 58891
Fax 34392 0
Email 34392 0
[email protected]
Contact person for public queries
Name 17639 0
Dr Amael Arguel
Address 17639 0
Centre for health Informatics
Level 1 AGSM Building (G27)
University of New South Wales
SYDNEY NSW 2052
Country 17639 0
Australia
Phone 17639 0
+61 02938 58691
Fax 17639 0
Email 17639 0
[email protected]
Contact person for scientific queries
Name 8567 0
Dr Annie Lau
Address 8567 0
Centre for health Informatics
Level 1 AGSM Building (G27)
University of New South Wales
SYDNEY NSW 2052
Country 8567 0
Australia
Phone 8567 0
+61 02938 58891
Fax 8567 0
Email 8567 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Embase"Why Didn't it Work?" Lessons From a Randomized Controlled Trial of a Web-based Personally Controlled Health Management System for Adults with Asthma.2015https://dx.doi.org/10.2196/jmir.4734
N.B. These documents automatically identified may not have been verified by the study sponsor.